🇨🇿 EUDAMED for manufacturers, importers and producers of procedure packs and systems

The event is held in Czech language only!

After long delays, the EUDAMED database will soon become an obligation for many medical device handlers. Unfortunately, along with the real outlines of this tool comes the realisation of the large amount of knowledge required, the technical pitfalls and the overall time-consuming processes involved in validation and mandatory data entry. The online seminar is intended for manufacturers, producers of procedure packs and systems, importers but also for other entities that are actively addressing the issue of meeting EU legislative requirements in connection with the launch of the EUDAMED database.

The introduction of the seminar will provide a complete overview of the requirements arising from the MDR and IVDR. The next part of the seminar will be devoted to a summary of the news related to the launch of the EUDAMED database, including an update on the implementation schedule for each module. All upcoming obligations for individual operators will be summarised, with particular emphasis on registration obligations. A significant part of the seminar will be devoted to the registration process itself. The process will be explained in practical terms for all types of devices, including legacy devices. Finally, the possibilities of bulk data processing and uploading (bulkuploads) will be presented. During the seminar, we will introduce the automated tool EUDAPORT, which greatly facilitates the registration process for medical devices and IVDs.

Who the webinar is for:

• regulatory specialists of manufacturers and producers of procedure packs and systems

• quality managers and PRRCs

• regulatory specialists of distributors and importers

• all those working in the healthcare sector who want up-to-date information on the practical use of the EUDAMED database

Lecturers:

• Jakub Musil

• Aleš Martinovský

Content:

• EUDAMED and its legislative anchoring in the text of the MDR and IVDR

• presentation of news, updated timetable and key dates for the implementation of the EUDAMED database

• obligations in relation to the EUDAMED database and their breakdown by economic operator

• the process of registration an economic operator (Actor registration module)

• the process of registration of MDs and IVDs (module “UDI/Devices registration”)

• obligations and registration process for legacy devices

• bulk upload of data to the EUDAMED database - practical hints and tips

• introduction of the automated tool EUDAPORT

Additional information:

• during the webinar, participants will have the opportunity to ask questions

• each participant will receive a certificate of participation

• a PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica s.r.o.

  ID: 03301931, VAT: CZ03301931

  registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město